Trial document




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  DRKS00000667

Trial Description

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Title

Hemodynamics during pacing-induced left bandle branch block compared to biventricular pacing

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Trial Acronym

SILVER-BI

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study investigates whether a pacing-induced decrease of cardiac-output by right-ventricular pacing could be reversed by bi-ventricular pacing.
In order to measure the cardiac-output and to stimulate the heart at different sites, cardiac catheters are inserted in the inguinal vessels and advanced to the heart. All measurements last approximately 60 minutes.

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Brief Summary in Scientific Language

Hemodynamic changes under right-ventricular compared to bi-ventricular pacing in patients with chronic heart failure NYHA II-IV and narrow QRS complex

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Organizational Data

  •   DRKS00000667
  •   2011/01/25
  •   [---]*
  •   yes
  •   Approved
  •   282/03, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1118-8323 
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Health Condition or Problem studied

  •   I50.9 -  Heart failure, unspecified
  •   I50.14 -  [generalization I50.1: Left ventricular failure]
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Interventions/Observational Groups

  •   right- and bi-ventricular pacing
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The increase of dP/dt during bi-ventricular stimulation is measured via an intracardiac pressure-wire. These measurements are performed during the procedure.

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Secondary Outcome

Cardiac output is determined under different V-V-intervals. For these measurements an intracardiac pressure-wire is used.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2011/01/21
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

• Standard indication for an electrophysiology study (EPS)
• Heart failure NYHA II-IV despite optimal medical treatment
• Left ventricular ejection fraction less than or equal to 40%
• Narrow QRS-complex (less than 120ms)

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Exclusion Criteria

• Underage patients
• Pregnant women
• Patients who attend other studies at the same time
• Persistant or permanent atrial fibrillation

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Addresses

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    • UNIVERSITÄTSKLINIKUM FREIBURG Medizinische Klinik III Kardiologie und Angiologie
    • Hugstetter Straße 55
    • 79106  Freiburg i. Br.
    • Germany
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    •   +49 761 270 3401 0
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    •   [---]*
    •   [---]*
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    • UNIVERSITÄTSKLINIKUM FREIBURG Medizinische Klinik III Kardiologie und Angiologie
    • Mr.  Dr. med.  Jürgen  Biermann 
    • Hugstetter Straße 55
    • 79106  Freiburg i. Br.
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • UNIVERSITÄTSKLINIKUM FREIBURG Medizinische Klinik III Kardiologie und Angiologie
    • Mr.  Dr. med.  Jürgen  Biermann 
    • Hugstetter Straße 55
    • 79106  Freiburg i. Br.
    • Germany
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Sources of Monetary or Material Support

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    • UNIVERSITÄTSKLINIKUM FREIBURG Medizinische Klinik III Kardiologie und Angiologie Hugstetter Straße 55 D-79106 Freiburg i. Br.
    • Hugstetter Straße 55
    • 79106  Freiburg i. Br.
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.